ISO 13485 Audit Prep: Top 3 Documents Auditors Check First

1. Management Review Minutes

Auditors start here to see if leadership is involved. If your minutes are generic or missing "Action Items" with due dates, you will get a non-conformance.

2. The CAPA Log (Corrective Actions)

An empty CAPA log is suspicious. A CAPA log with open items older than 90 days is a red flag. Auditors want to see that you identify problems and actually close them.

3. Risk Management File (ISO 14971)

Your Risk Assessment must be a living document. It must be updated based on post-market feedback. If your Risk file hasn't been touched since the product launch, you are non-compliant.